Computer System Validation & Jira

Computer system validation and Jira

How to use GAMP® 5 principles and Jira to expedite validation

Join us on the 3.10.2018 in London, UK

Practical Solutions in CSV and SDLC for GXP & MedDev

Practical Solutions in CSV and SDLC for GXP & MedDev

Join us on the 27.11.2018 in Stuttgart, Germany

How to validate software development tools used for GXP and MedDev?

You can even use this reference to validate Jira itself

When does a software tool require validation?

If software tools are used for any process which affects your product or quality systems, then that process has to be validated. A key distinction is that it is not the software tool as a stand alone product which needs to be validated, but rather your actual use of the product within your specific intended use which needs to be validated.
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Planning for Validation

Planning your project and planning your validation are very closely intertwined, and when your project process is mature, then these will converge to be the same thing.
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Process mapping

Before embarking on the project, it is important to first agree on the eventual business process. This is why a process mapping exercise is critical; it provides you with the opportunity to gather input from stake holders and process participants alike, and align everyone around a common goal.
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Contributors

Rina Nir

CEO, Radbee

Markus Roemer

Consultant, Comes compliance services

Join us on the 27.11.2018 in Stuttgart, Germany

How to validate software development tools used for GXP and MedDev?